1. Field of the Invention
The present invention generally relates to medical devices for performing medical procedures, such as a cricothyrotomy, thoracostomy, or chest decompression and/or drainage and more particularly, to an airway creation assist device (AACAD) for proper identification of the airway tube insertion site, proper incision into or puncture of the trachea, proper placement and securement of an airway tube, and securing the tube in place. A chest decompression assist device is also disclosed for the drainage of air and/or fluid from the chest.
2. Description of Prior Art
Studies suggest that many wartime casualties could be avoided if interim tools and procedures could be implemented to allow non-experts to perform certain procedures before the injured patient can be transported to a surgeon. For example, obstruction of the airway is still one of the most common preventable causes of death on the battlefield. Eastridge, Brian et al., “Death on the Battlefield (2001-2011): Implications For The Future Of Combat Casualty Care, Jnl of Trauma and Acute Care Surgery, vm 73, Issue 6, pp S431-S437 (December, 2012). Cricothyrotomy (also called thyrocricotomy, cricothyroidotomy, inferior laryngotomy, intercricothyrotomy, coniotomy or emergency airway puncture) is a medical procedure wherein an incision is made through the skin and cricothyroid membrane to establish a patent airway during certain life-threatening, situations when trauma or obstructions prevent more common, less traumatic air ix management techniques, e.g., orotracheal or nasotracheal intubation. There are two commonly accepted types of cricothyrotomy procedures: (1) surgical cricothyrotomy and (2) percutaneous cricothyrotomy. In the surgical type, a scalpel is used to make an incision in the skin and through the cricothyroid membrane, into the trachea, which is then opened to insert a cricothyrotomy tube, in the percutaneous type, a needle that extends through a catheter is inserted through the cricothyroid membrane and into the trachea. After reaching the trachea, the catheter is advanced along the inserted needle, into the trachea, and then the needle is removed. Examples of the percutaneous approach are the modified Seldinger technique and direct airway placement. The surgical cricothyrotomy has been the preferred technique in combat. MacIntyre, A., Markarian, M. K., Carrison, D., Coates, J., Kuhls, D., and Fildes J. J., “Three-Step Emergency Cricothyroidotomy”, Military Medicine, 172(12): 1228-1230 (2007). Regardless of the type of procedure employed, locating the cricothyroid membrane is critical in performing the procedure effectively. For this reason, relative to the subject invention, “percutaneous” is herein defined as any through-the-skin approach: catheter over needle, surgical, open dissection, etc. Anatomical landmarks are used to manually locate the cricothyroid membrane, such as the thyroid cartilage and laryngeal prominence (Adam's apple). Complications can arise in performing the procedure, however, including esophageal perforation, subcutaneous emphysema, and hemorrhage. Hsiao, S. and Pacheco-Fowler, V., “Cricothyroidotomy,” New England Journal of Medicine, 358(22) 25 (2008). The more common mistakes or failures in performing cricothyrotomies are related to improper placement and improper insertion depth. Difficulties have been reported in maintaining correct alignment between the incision in the skin tissue and the cricothyroid membrane using the standard surgical procedure, for example, which can lead to cutting into or introducing a catheter into tissue adjacent to the trachea, rather than the trachea itself. Clancy, M. J., “A Study Of The Performance Of Cricothyroidotomy On Cadavers Using The Minitrach II”, Archives of Emergency Medicine, 6: 143-145 (1989). Moreover, lesions and even perforations of the posterior tracheal wall are a common complication related to incorrect insertion depth of the needle and/or catheter, the prevalence of which can vary depending on the type of tools used in performing the cricothyrotomy. Benkhadra, M., Lenfant, F., Menetz, W. Anderhuber, F., Feigl, G., and Fasel, J., “A Comparison of Two Emergency Cricothyroidotomy Kits in Human Cadavers”, International Anesthesia Research Society, 106(1): 182-185 (2008).
It has been reported from recent conflicts in Iraq and Afghanistan that only 68% of pre-hospital cricothyrotomies were successful, and that this nearly ⅓ chance of failure from military medics was more than twice the failure rate (15%) of physicians or physician assistants. Mabry, R. L. and Frankfurt, A., “An Analysis of Battlefield Cricothyrotomy in Iraq and Afghanistan”, Journal of Special Operations Medicine, 12(1): 17-23 (2012).
Even more prevalent are thoracic injuries, which occurred in nearly 10% of wounded personnel in recent military engagements. Ivey, K. M., et al., 2012 “Thoracic injuries in US combat casualties: a 10-year review of Operation Enduring Freedom and Iraqi Freedom,” Journal of Trauma Acute Care Surgery, 73(6 Suppl 5): S514-S519. Tension pneumothorax, consequence of thoracic trauma, is among the top three most common causes of preventable combat death. Eastridge, Brian et al., “Death on the Battlefield (2001-2011): Implications For The Future Of Combat Casualty Care, Jnl of Trauma and Acute Care Surgery, vm 73, Issue 6, pp S431-S437 (December 2012). The medical procedure of tube thoracostomy, also known as chest tube decompression or intercostal drain, is the most definitive initial treatment to manage thoracic injury. This procedure is likewise commonly performed incorrectly, with tube malposition occurring over 30% of the time, and the most frequent major complication associated with tube thoracostomy is non-relieved tension pneumothorax. Aylwin, C. J., 2008. “Pre-Hospital and In-Hospital Thoracostomy: Indications and Complications,” Ann R Coll Surg Engl, 90(1): 54-57. In the related needle decompression, high failure rates have been reported with over 40% resulting from incorrect needle location. Netto, F. A. C. S., et al., “Are needle decompressions for tension pneumothoraces being performed appropriately for appropriate indications?” The American Journal of Emergency Medicine, 26: 597-602 (2008). One approach to performing chest decompression has the user insert the medical instrument (e.g., needle) in an area under the axilla (armpit) delineated by a horizontal line at the nipples and the latissimus dorsi and pectoralis major. Here as well erroneous placement of the needle increases the risk of damage to internal blood vessels and mediastinal structures.
Contributors to procedural failure on the battlefield include limited training and experience of combat medics relative to physicians, and the battlefield environment itself, it has been shown, for example, that stressful conditions can adversely affect clinical skill. Moorthy, K., Munz, Y., Dosis, A., Bannm, S., Darzi, A., “The Effect Of Stress-Inducing Conditions On The Performance Of A Laparoscopic Task,” Surgical Endoscopy, 17(9): 1481-1484 (2003). There is likely no condition more stressful than a battlefield. Since the procedure may need to be performed by combat medics or fellow soldiers, as simplified and more reliable procedure is imperative. The 15% failure rate observed with physicians and physician assistants performing this emergency life-saving procedure indicates a need for improving the procedure for more skilled providers as well. Realizing this need, as recent review of tactical combat casualty care has identified five areas in need of improvement related to the procedure: (1) limited anatomy knowledge and inadequate transfer to practical skill; (2) lack of hands-on anatomy familiarization; (3) nonstandardized procedure; (4) inferior industry standard for training mannequins; and (5) lack of refresher training. Bennett, B. L., Cailteux-Zevallos, B., and Kotora. J., “Cricothyroidotomy Bottom-Up Training Review: Battlefield Lessons Learned,” Military Medicine, 176(11): 1311-1319 (2011).
Several kits have been developed in an attempt to simplify the procedure or reduce the number of tools needed, but none have demonstrated statistically significant improvement above the standard issue cricothyrotomy kits (surgical method). For example, Chinook Medical sells an emergency cricothyrotomy kit that contains a scalpel, cuffed endotracheal tube, syringe, curved hemostat, and tracheal hook. The Rüsch QuickTrach® cricothyrotomy kit has fewer individual parts, presumably simplifying the procedure, but this comes at the expense of a more complicated and costly whole. The CRIC™ device from Pyng Medical is a multi-tool designed for military use that incorporates a clipped-in sterilizing wipe, tie-down strap, light, tissue spreader, and retractable scalpel into a single small tool.
A number of these kits were recently compared in a porcine model study using, participants that were trained in surgical cricothyrotomy, but untrained with the three different kits evaluated. Murphy, C., Rooney, S. J., Maharaj, C. H., Laffey, J. G., and Harte, B. H., “Comparison Of Three Cuffed Emergency Percutaneous Cricothyroidotomy Devices To Conventional Surgical Cricothyroidotomy In A Porcine Model,” British Journal of Anaesthesia, 106(1): 57-64 (2011). While one of the kits was subjectively rated as being slightly easier to use than the standard surgical tools, it took over 50% longer to complete the procedure with the “easier” kit than with the standard surgical kit (94 sec vs. 59 sec) in an operating room environment. This duration is similar to a second reported study (54 s) in an operating room environment for the surgical procedure, thereby establishing a baseline between the two studies. The second study also compared results of simulated combat environments. Walsh, R, Hiener, J., Kang, C., Hile, D., and Deering, S., “Emergency Physician Evaluation of a Novel Surgical Cricothyroidotomy Tool in Simulated Combat and Clinical Environments”, Military Medicine, 178(1): 29-33 (2013). These findings showed that the average time thin reaching a patient to achieving successful intubation with the surgical method was approximately 45 sec, which is 17% faster, but a greater complication rate was reported.
In addition to successfully performing a cricothyrotomy, these studies highlight two other related aspects. The first is that the number of tools in the kit is not directly proportional to the time required for task completion or complication rate, and the second is that stressful environments (e.g., combat) may reduce efficacy. It is therefore paramount that a truly effective cricothyrotomy device or kit be easy to use and intuitive, considerations which have proven to be unattainable for the standard surgical kit. Mabry. R. L. and Frankfurt, A., “An Analysis of Battlefield Cricothyrotomy in Iraq and Afghanistan”, Journal of Special Operations Medicine, 12(1): 17-23 (2012). These studies also call attention to another important metric, which is the amount of time required to establish an airway (more than 300 sec was considered failure).
Based upon this brief review of emergency cricothyrotomies, it can be concluded that the primary factors affecting the efficacy of the procedure, are: (1) proper identification of the insertion site, (2) proper incision into or puncture of the trachea, (3) proper insertion of the cricothyrotomy tube (including both placement and securement), and (4) time to cricothyrotomy tube placement.
The previous discussion has elucidated the fact that none of the existing cricothyrotomy kits perform noticeably better than the standard surgical kit, if not worse, and given the high reported failure rate in combat situations when using the standard, multi-part surgical kit, a new solution is motivated.
While much of this discussion has focused on cricothyrotomy, this is because a number of tools have been developed in attempts to improve this particular procedure. The far more common procedure chest decompression and drainage has regretfully experienced far less effort for improvement and there are no existing tools that aid the user in identifying the proper insertion site.
Other prior art has attempted to address some of these noted issues for cricothyrotomies or related procedures. For example, U.S. Pat. No. 3,791,386 (McDonald) shows a tracheotomy assist device for those lacking medical training that includes an indexing frame with a chinrest that is secured to the patient's neck and a rotation knob that pokes three holes into the trachea. U.S. Pat. No. 3,991,765 (Cohen) shows a cricothyrotomy apparatus that performs the procedure automatically with a spring-loaded blade and spring-loaded tube contained in a housing. U.S. Pat. No. 7,267,124 (Robertson et al.) shows a kit to facilitate tracheostomies that includes a template guide to place on a patient to indicate the incision location, a cutting instrument, and a breathing tube. U.S. Pat. No. 7,347,840 (Findlay et al.) shows an apparatus for locating a site of intraosseous infusion that includes an adhesive template patch with a target zone located a predetermined distance away from an anatomical feature. U.S. Pat. No. 8,151,791 (Arlow et al.) shows a tracheotomy device with a curved dilator with an inner passageway that acts as an anchor, U.S. Pat. No. 7,373,939 (DuBois et al.) shows an integrated tracheotomy tool using a pistol-grip impact-driven trocar delivery mechanism that can be actuated impulsively.
Aside from the fact that cricothyrotomies are fundamentally different procedures than tracheostomies and tracheotomies, particularly in emergency situations such as on the battlefield, none of this prior art adequately addresses all of the underlying problem areas. As noted above, the same is true for other medical procedures, such as tube thoracostomies and needle decompression. What is needed is an assist device for guiding medical procedures, including cricothyrotomies, needle decompression, tube thoracostomies, and other percutaneous procedures with universal applicability that significantly improves the success rate and effectiveness of performing the procedures.